By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries. Most HIV-infected children are infected by transmission from mother to child during pregnancy, at birth, or through breast milk. Antiretroviral medications, cesarean section before rupture of membranes, and avoidance of breastfeeding are ways to reduce the risk of transmission. This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery.

Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study. HIV-infected women will be evaluated during pregnancy, during delivery, and 6 months after delivery. At each visit, a history will be taken and physical examination given; blood will be collected for laboratory tests.

HIV-exposed infants will be evaluated through 6 months of age. At each of 2 visits, a history will be taken and physical examination given; blood will be collected for laboratory tests; and growth will be assessed.

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Primary Outcome Measure: To describe the characteristics of HIV-infected pregnant women and their HIV-exposed children in Latin America, including the rates of and risk factors for mother-to-child transmission

Secondary Outcome Measures:

Secondary Outcome Measure: To characterize adverse events according to receipt of and exposure to ARVs (by HIV-infected women during pregnancy and postpartum and by their HIV-exposed but uninfected children in utero and during the first few week...

Estimated Enrollment:

5000

Study Start Date:

July 2002

Detailed Description:

Prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed, uninfected children followed at participating Latin American sites, and to characterize adverse events during pregnancy and the postpartum period (HIV-infected women) and during childhood (HIV-exposed, uninfected children) according to receipt of/exposure to antiretroviral drug(s) .

The study population is comprised of HIV-infected pregnant women and HIV-exposed infants/children.

HIV-infected Women: The study enrolled HIV-infected pregnant women receiving medical care at participating clinical sites who: 1) plan to deliver at the clinical site; and 2) plan to continue postpartum and routine medical care for up to 5 years at the clinical site or associated outpatient facility.

The Pediatric Cohort consists of HIV-exposed, uninfected children born to enrolled HIV-infected women. They were followed for up to 5 years. (HIV-exposed children ultimately determined to be HIV-infected were offered enrollment in a separate study, if eligible.)

In addition, the NISDI study is using data from a locally conducted, single-site maternal-child health cohort study in Brazil (enrolled HIV-uninfected pregnant women and their HIV-unexposed infants) for NISDI analyses that benefit from making comparisons to healthy controls

Eligibility

Ages Eligible for Study:

up to 50 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA: (HIV-Infected Pregnant Women)

Documentation of pregnancy, using one or more of the following:

Urine HCG pregnancy test;

Serum HCG pregnancy test;

Positive fetal heart tones by Doppler; or

Ultrasound.

Documentation of HIV infection, defined by any two of the following prior to or during pregnancy:

Reactive test for HIV antibody;

Positive HIV culture;

Positive HIV DNA PCR;

Positive neutralizable HIV p24 antigen;

Positive qualitative HIV RNA;

Quantitative HIV RNA greater than or equal to 1000 copies/ml; and

Diagnosis of AIDS-defining clinical condition.

Willingness and intent to deliver at the participating clinical site and to be followed through six months postpartum at the site or associated outpatient facility.

Willingness and ability to sign informed consent-Subject must be of an age to provide legal informed consent as defined by the country in which the subject resides.

Willingness and intent to have infant followed through six months of age.

Subjects may be co-enrolled in clinical trials for treatment or prophylaxis of HIV infection, opportunistic infections, or other HIV related problems.

Subjects may be re-enrolled with subsequent pregnancies during the study.

Subjects may enroll up to and prior to delivery, including during labor.

EXCLUSION CRITERIA: (HIV-Infected Pregnant Women)

Failure to meet inclusion criteria.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341302